Study on Detecting Circulating Tumor DNA in Small Blood Samples Using Automated Capillary Sampling in Adults with Colorectal Liver Metastases

What this Trial Is About

Researchers are investigating whether circulating tumor-derived DNA ctDNA can be reliably detected in small blood samples collected through automated capillary sampling in adults aged 21 years and older with colorectal liver metastases CRLM. The study aims to compare ctDNA levels in capillary blood to those in venous blood to assess if the less invasive capillary method provides accurate results. This observational study is sponsored by Erasmus Medical Center and focuses on the feasibility of using this new sampling technique for ctDNA analysis in colorectal cancer care. Participants will provide a small capillary blood sample collected using an automated TAP4 device and a venous blood sample collected in a 10 mL EDTA tube during the same visit. The venous blood serves as the reference standard for ctDNA measurement. This proof-of-concept study will enroll about 35 patients with progressive colorectal liver metastases to assess the technical feasibility and correlation of ctDNA detection between the two blood collection methods. During the study visit, participants will give both types of blood samples. Researchers will measure ctDNA levels in both samples to evaluate agreement and technical feasibility. The primary outcome is the ability to detect ctDNA in small capillary blood volumes, while secondary outcomes include the correlation of variant allele frequency VAF between capillary and venous blood. The study is expected to complete by November 2027.

Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling